Cleared Traditional

K925012 - PLASTIC CHAIN

K925012 is an FDA 510(k) clearance for PLASTIC CHAIN, manufactured by American Orthodontics. The device is a Class 1 Dental device with product code EJF cleared through the Traditional 510(k) pathway after a 346-day FDA review.

K925012 · American Orthodontics · Dental device
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Sep 1993
Decision
346d
Days
Class 1
Risk

K925012 is an FDA 510(k) clearance for the PLASTIC CHAIN. Classified as Bracket, Metal, Orthodontic (product code EJF), Class I - General Controls.

Submitted by American Orthodontics (Sheboygan, US). The FDA issued a Cleared decision on September 13, 1993 after a review of 346 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5410 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all American Orthodontics devices

FDA 510(k) Submission Details - K925012

510(k) Number K925012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1992
Decision Date September 13, 1993
Days to Decision 346 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
219d slower than avg
Panel avg: 127d · This submission: 346d
Pathway characteristics
Predicate-based equivalence.

EJF Device Classification - Class 1, General Controls

Product Code EJF Bracket, Metal, Orthodontic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.5410
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EJF Bracket, Metal, Orthodontic

All 46
Devices cleared under the same product code (EJF) and FDA review panel - the closest regulatory comparables to K925012.
FASCINATION CERAMIC BRACKET
K935139 · Dentauraum, Inc. · Feb 1994
DENTAURUM METAL BRACKETS
K935122 · Dentauraum, Inc. · Jan 1994
ORMCO SPORTSGUARD
K922806 · Ormco Corp. · Oct 1993
THE HERBST APPLIANCE
K923405 · Ormco Corp. · May 1993
ORTHODONTIC METAL BRACKET
K923261 · American Orthodontics · Dec 1992
GERMAN MINI DYNALOCK
K923432 · Unitek Corp. · Oct 1992